MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2 CATHETER WITH SHERLOCK TLS TECHNOLOGY 5F; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of reew2964 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "hospital has a broken wire tip today." additional info.Received 02/04/2021 "picc was placed on left side using ultrasound modified seldinger method use.The vein was cannulated without issue, the wire was threaded thru needle, needle removed, introducer threaded overwire.Wire removed attempt to thread picc.It would only go a little past shoulder.After repositioning pt and several attempt to place, a nitinol wire was use in the purple lumen it was able to move down to svc.Nitonol wire removed intact.Sherlock wire removed.From red port.Both ports flushed easily with good blood return.The sherlock wire was noted to be curled up but seemed to be intact.Xray taken: the picc terminated in the hemizygous vein probably due to stenous of the brachiocephalic vein.Foreign body was noted in brachiocephalic vein.Pt was taken to ct confirmed wire fragment.Pt was taken to cath lab and the wire was retrieved by the ir md.Picc was pulled.".
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken stylet was confirmed; however, the root cause was not identified.The product returned for evaluation was one 5fr d/l powerpicc catheter.Usage residues were observed throughout the sample.A fragment of tls stylet was received with the catheter.The fragment included the distal tip and several magnets.Kinks were observed between several of the magnets.Microscopic inspection of the stylet revealed discoloration and deformation in the vicinity of the break.The tubing exhibited an irregular and elliptical cross-section at the break site.The polyimide tubing wall thickness was measured at multiple points using a digital microscope.The measurements were found to be within manufacturing specifications.Manipulation of the stylet appeared to contribute to the observed device deformation; however, an additional unidentified factor(s) may have contributed.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.
Event or Problem Description
It was reported "hospital has a broken wire tip today." additional info.Received 02/04/2021 "picc was placed on left side using ultrasound modified seldinger method use.The vein was cannulated without issue, the wire was threaded thru needle, needle removed, introducer threaded overwire.Wire removed attempt to thread picc.It would only go a little past shoulder.After repositioning pt and several attempt to place, a nitinol wire was use in the purple lumen it was able to move down to svc.Nitonol wire removed intact.Sherlock wire removed.From red port.Both ports flushed easily with good blood return.The sherlock wire was noted to be curled up but seemed to be intact.Xray taken: the picc terminated in the hemizygous vein probably due to stenous of the brachiocephalic vein.Foreign body was noted in brachiocephalic vein.Pt was taken to ct confirmed wire fragment.Pt was taken to cath lab and the wire was retrieved by the ir md.Picc was pulled." it was reported via medwatch "tip of guidewire protruded from 5 fr power picc resulting in 37mm of the tip of sherlock wire to break off from wire causing a retained foreign object x-ray images used used to verify placement and removed by doctor images were taken to confirm placement and removed by doctor images were taken to confirm placement of rfo, 2 other events within the last six months using the 5 fr power picc resulted in rfo after procedure.".

• Brand Name: POWERPICC SOLO2 CATHETER WITH SHERLOCK TLS TECHNOLOGY 5F
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11395948
• Report Number: 3006260740-2021-00575
• Device Sequence Number: 16965709
• Product Code: LJS
• UDI-Device Identifier: 00801741035760
• UDI-Public: (01)00801741035760
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 9295108D
• Device Lot Number: REEW2964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR